DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination
In view of the Appeal Brief filed on 10/29/2025, PROSECUTION IS HEREBY REOPENED. A new ground of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/MARIS R KESSEL/
Supervisory Patent Examiner, Art Unit 1758
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 10-12, 15, and 21-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hudson et al. (US20170307605).
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Annotated Figure 1
Regarding claim 1, Hudson et al. teaches a swab device (lateral flow device, see annotated Figure 1), comprising:
a handle shaft (sink, see Figure 1);
a collection element, including absorbent swab material, positioned on a distal end of the handle shaft to collect, in the absorbent swab material, a biological sample from a human body (sample receiving portion including permeable membrane, see Figure 1, where the sample is made of an absorbent material to accept a biological sample, see [0048] and [0052] – [0054], the sample receiving portion is also in the shape of an oval, see [0054]); and
an embedded test element completely embedded in the collection element to perform a test on the collected sample and provide an indication of a result of the test on the collection element (test and control sites embedded into permeable membrane used to indicate a presence of an analyte on collection element, see Figure 1, [0083], and [0093]- [0094]), wherein the test element includes a test line element embedded in the collection element to provide an indication on the collection element on the distal end of the handle shaft of whether a target analyte is present in the biological sample collected from the human body (test site for indicating the presence of an analyte, see [0083]) and a control line element embedded in the collection element to indicate on the collection element on the distal end of the handle shaft whether the test is valid (control site indicates whether the test has worked, see [0094]), and wherein the embedded test element includes a lateral flow assay (LFA) test element (test and control sites constitute a lateral flow assay, see [0201]).
Regarding claim 4, Hudson et al. teaches the swab device of claim 1 (see above), wherein the embedded test element is positioned near a center of the collection element (see test and control site on annotated Figure 1), and wherein the collection element includes a first portion of the absorbent swab material proximal to the embedded test element (sample receiving portion, see Figure 1) and a second portion of the absorbent swab material distal to the embedded test element (distal end of permeable membrane, see Figure 1), and wherein the embedded test element provides the indication of the result of the test on the collection element between the first and second portions of the absorbent swab material (the results are shown at the test site and control site, located between the sample receiving portion and distal permeable membrane, see Figure 1).
Regarding claim 10, Hudson et al. teaches the swab device of claim 1 (see above), wherein the embedded test element comprises a continuous test strip (see Figure 1).
Regarding claim 11, Hudson et al. teaches the swab device of claim 1 (see above), wherein the embedded test element comprises two separate embedded discs (the test site and control site are separate embedded bands, or discs, see Figure 1).
Regarding claim 12, Hudson et al. teaches the swab device of claim 1 (see above), wherein an assay solution is applied to the collection element as part of the test (a buffer solution is applied to the sample receiving portion, see [0038]).
Regarding claim 15, Hudson et al. teaches a swab device (lateral flow device, see annotated Figure 1), comprising:
a handle shaft (sink, see Figure 1);
a collection element with absorbent swab material positioned on a distal end of the handle shaft to collect, in the absorbent swab material, a biological sample from a human body (sample receiving portion including permeable membrane, see Figure 1, where the sample is made of an absorbent material to accept a biological sample, see [0048] and [0052] – [0054], the sample receiving portion is also in the shape of an oval, see [0054]); and
a test element completely embedded in the collection element to perform a test on the collected sample and provide an indication of a result of the test on the collection element , wherein the embedded test element includes a lateral flow assay (LFA) test element (test and control sites embedded into permeable membrane used to indicate a presence of an analyte on collection element, see Figure 1, [0083], and [0093]- [0094], where test and control sites constitute a lateral flow assay, see [0201]), and wherein the test element includes a test line element embedded in the collection element to provide an indication on the collection element on the distal end of the handle shaft of whether a target analyte is present in the biological sample (test site for indicating the presence of an analyte, see [0083]) and a control line element embedded in the collection element to indicate on the collection element on the distal end of the handle shaft whether the test is valid (control site indicates whether the test has worked, see [0094]), and wherein the embedded test element includes a lateral flow assay (LFA) test element (test and control sites constitute a lateral flow assay, see [0201]).
Regarding claim 21, Hudson et al. teaches the swab device of claim 1, wherein the biological sample is one of a saliva sample, a nasal secretion sample, a blood sample, an oropharyngeal sample, a penile sample, a rectal sample, or a vaginal sample (the sample is blood, urine, or saliva, see [0002]).
However, the Examiner notes that inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims. In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
Regarding claim 22, Hudson et al. teaches the swab device of claim 1, wherein the collection element has a width that is greater than a width of the handle shaft (the width of the sample receiving portion is wider than the handle shaft, see Annotated Figure 1).
Regarding claim 23, Hudson et al. teaches the swab device of claim 22, wherein the collection element has a length that is smaller than a length of the handle shaft (the length of the test and control sites is shorter than that of the sink, or handle shaft area, see annotated Figure 1).
Regarding claim 24, Hudson et al. teaches the swab device of claim 1, wherein the test element is configured to generate a thermal signature to be read by a thermal contrast reader (the test site and control site change color according to a detected wavelength, see [0076], and therefore generate a thermal signature for a thermal contrast reader).
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 5, Hudson et al. teaches the swab device of claim 1, but does not teach that the embedded test element is positioned at a proximal end of the collection element and wherein the absorbent swab material of the collection element is positioned distal to the embedded test element, and wherein the embedded test element provides the indication of the result of the test on the proximal end of the collection element.
Instead, the prior art reference teaches that the absorbent swab member is located proximal to, or ahead of, the embedded test element comprising the test and control sites. It is unclear how a person possessing ordinary skill in the art before the effective filing date of the instant application would have modified the invention of Hudson to place the absorbent test member distal to the embedded test member as the sample receiving portion of Hudson et al. is required to accept a sample prior to buffer application, see [0015].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gold et al (US2009/0197283) teaches a swab device with a lateral flow strip therein.
Stone (US5550061) teaches a swab device for colorimetric testing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEA MARTIN whose telephone number is (571)272-5283. The examiner can normally be reached M-F 10AM-5:00PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
